Do Compression Stockings Used During Cesarean Sections Affect Intraoperative Hypotension and Nausea?

NCT ID: NCT06707428

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-05

Study Completion Date

2024-06-25

Brief Summary

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The present study aimed to determine the effects of compression stockings used during cesarean section on intraoperative hypotension.

Detailed Description

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Cesarean section is among the most common surgeries in young and healthy individuals. Its frequency is increasing in our country and on a global scale. A total of 57% of all births in our country were performed by cesarean section between 2018 and 2023.

Spinal anesthesia is frequently used during cesarean sections with its advantages such as the patient being conscious, not having a risk of aspiration, not causing respiratory depression in the newborn, and the mother being able to breastfeed early. However, Spinal Anesthesia has complications such as hypotension and post-spinal headache, bradycardia and asystole, nausea, hypoventilation, total spinal block, urinary retention, spinal hematoma, back pain, infection, transient neurological symptoms, or cranial nerve paralysis. The present study aimed to determine the effects of compression stockings used during cesarean section on intraoperative hypotension.

Conditions

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Intraoperative Hypotension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Compression stocking using group

Wearing varicose vein stockhing is a routine operation preparation

Group Type EXPERIMENTAL

compression stockings

Intervention Type OTHER

compression stockings used during cesarean section

Control Group

Routine opreration preparation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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compression stockings

compression stockings used during cesarean section

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

37-38 weeks pregnant women

Exclusion Criteria

* chronic disease
* women who developed complications during surgery
* women with multiple pregnancies
* women with pregnancies with known fetal anomalies
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Seçil Yavaş

Ph.D. student in women's health and diseases nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Afşin Devlet Hastanesi

Afşin, Kahramanmaraş, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Pradhan, A., Das, T., Sraban, S., Pradhan, K., & Raut, K. (2016). Study the Hemodynamic changes after leg wrapping in elective cesarean section under spinal anesthesia. J Med Sci Clin Res, 4(11), 12-20.https://doi.org/10.18535/jmscr/v4i11.66

Reference Type BACKGROUND

Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.

Reference Type BACKGROUND
PMID: 29090733 (View on PubMed)

Ferre F, Martin C, Bosch L, Kurrek M, Lairez O, Minville V. Control of Spinal Anesthesia-Induced Hypotension in Adults. Local Reg Anesth. 2020 Jun 3;13:39-46. doi: 10.2147/LRA.S240753. eCollection 2020.

Reference Type BACKGROUND
PMID: 32581577 (View on PubMed)

Chang YJ, Liu CC, Huang YT, Wu JY, Hung KC, Liu PH, Lin CH, Lin YT, Chen IW, Lan KM. Assessing the Efficacy of Inferior Vena Cava Collapsibility Index for Predicting Hypotension after Central Neuraxial Block: A Systematic Review and Meta-Analysis. Diagnostics (Basel). 2023 Aug 31;13(17):2819. doi: 10.3390/diagnostics13172819.

Reference Type BACKGROUND
PMID: 37685357 (View on PubMed)

Ağaçayak, E., Yavuz, M., Tunç, S. Y., Akın, G., Ertuğrul, S., Yıldırım, Z. B., & Gül, T. (2019). Comparison neonatal outcomes of elective cesareans performed with spinal or general anesthesia and normal births without anesthesia. Dicle Medical Journal , 46(2), 299-305.https://doi.org/10.5798/dicletip.574822

Reference Type BACKGROUND

Adatepe S. (2020). Comparison of neonatal outcomes of elective cesarean sections performed with spinal or general anesthesia and normal deliveries without anesthesia.Specialization Thesis. Tokat Gaziosmanpaşa University.

Reference Type BACKGROUND

Yu C, Gu J, Liao Z, Feng S. Prediction of spinal anesthesia-induced hypotension during elective cesarean section: a systematic review of prospective observational studies. Int J Obstet Anesth. 2021 Aug;47:103175. doi: 10.1016/j.ijoa.2021.103175. Epub 2021 May 1.

Reference Type RESULT
PMID: 34034957 (View on PubMed)

Ebrahim Elgzar WT, Ebrahim Said H, Ebrahim HA. Effect of lower leg compression during cesarean section on post-spinal hypotension and neonatal hemodynamic parameters: nonrandomized controlled clinical trial. Int J Nurs Sci. 2019 Jun 10;6(3):252-258. doi: 10.1016/j.ijnss.2019.06.003. eCollection 2019 Jul 10.

Reference Type RESULT
PMID: 31508443 (View on PubMed)

Ulgu MM, Birinci S, Altun Ensari T, Gozukara MG. Cesarean section rates in Turkey 2018-2023: Overview of national data by using Robson ten group classification system. Turk J Obstet Gynecol. 2023 Sep 4;20(3):191-198. doi: 10.4274/tjod.galenos.2023.68235.

Reference Type RESULT
PMID: 37667479 (View on PubMed)

Mohamed AI, Elazhary RA, Abdelhady RM, Abd-ElSadek BR, Said KM. Utilization of lower leg compression technique for reducing spinal induced hypotension, and related risks for mothers and neonates during cesarean delivery. J Nurs Educ Pract 2016;6(7):11e8. https://doi.org/10.5430/jnep.v6n7p11

Reference Type RESULT

Mohamad A., Rama B., Farshid G., Kourosh F., Reza A. (2020). A randomized double-blind clinical trial evaluating the effect of Elastic Stocking on Hemodynamic Changes and dose use of ephedrine for elective cesarean surgery under spinal anesthesia. International Journal of Surgery Open, 27, 58-63, https://doi.org/10.1016/j.ijso.2020.10.019

Reference Type RESULT

Wan L, Shen PY, Zhang SX, Wang LZ. Leg Compression Versus Control for Prevention of Spinal Anesthesia Induced Hypotension in Elective Cesarean Delivery: A Meta-Analysis of Randomized Controlled Trials. J Perianesth Nurs. 2022 Aug;37(4):501-508. doi: 10.1016/j.jopan.2021.10.011. Epub 2022 Mar 4.

Reference Type RESULT
PMID: 35256251 (View on PubMed)

Yao HQ, Huang JY, Dong YF, Sun XX, Wang LZ. Effect of pneumatic leg compression on phenylephrine dose for hypotension prophylaxis via variable rate infusion at cesarean delivery: an unblinded randomized controlled trial. Int J Obstet Anesth. 2024 Nov;60:104218. doi: 10.1016/j.ijoa.2024.104218. Epub 2024 Jun 11.

Reference Type RESULT
PMID: 38925990 (View on PubMed)

Hasanin A, Aiyad A, Elsakka A, Kamel A, Fouad R, Osman M, Mokhtar A, Refaat S, Hassabelnaby Y. Leg elevation decreases the incidence of post-spinal hypotension in cesarean section: a randomized controlled trial. BMC Anesthesiol. 2017 Apr 24;17(1):60. doi: 10.1186/s12871-017-0349-8.

Reference Type RESULT
PMID: 28438121 (View on PubMed)

Other Identifiers

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ErciyesU-SBE-SY-01

Identifier Type: -

Identifier Source: org_study_id